CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median OS by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

maximal cytoreductive surgery with or without HIPEC For HIPEC : the cisplatin will be used at 75mg/m2

Experimental: maximal cytoreductive surgery with HIPEC

Procedure: maximal cytoreductive surgery

maximal cytoreductive surgery with or without HIPEC For HIPEC : the cisplatin will be used at 75mg/m2

Detailed Description:

The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.

So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:

either treatment A = maximal cytoreductive surgery without HIPEC

or treatment B = maximal cytoreductive surgery with HIPEC

The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual < 0.25cm).

Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient age ≥ 18 yrs,

Performance Status OMS < 2,

Initially treated for Epithelial Ovarian Carcinoma

Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)

Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx

Complete cytoreductive surgery

The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy

Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule,

Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC,

Patient already treated with HIPEC for the ovarian cancer

Individual deprived of liberty or placed under the authority of a tutor.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376752